Recalls / Class II
Class IID-1372-2022
Product
Ready in case ACETAMINOPHEN PM CAPLETS 24 CT SKU 900559; TYLENOL CHILD GRAPE 4 FL OZ SKU 901600 TYLENOL CHILD ORAL SUSPENSION CHERRY 4 FO 913104 TYLENOL INFANTS DROPS DF CHERRY 1OZ SKU 999108 TYLENOL PM CAPLET 24 CT SKU 900603 TYLENOL EXTRA STRENGTH CAPLET 24 CT SKU 916986 TYLENOL 8HR MSL ACHE PAIN RD CAPLET 24 CT SKU 901155 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Affected lot / code info
- SKUs:900559; 901600; 913104; 999108; 900603; 916986; 901155
Why it was recalled
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recalling firm
- Firm
- Family Dollar Stores, Llc.
- Notification channel
- Other
- Type
- Voluntary: Firm initiated
- Address
- 500 Volvo Pkwy, Chesapeake, Virginia 23320-1604
Distribution
- Quantity
- Unknown
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-06-23
- FDA classified
- 2022-08-22
- Posted by FDA
- 2022-08-31
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1372-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.